Quality Control Inspector I (1st shift)

Glaukos•San Clemente, CA

48d•Onsite

About The Position

The Quality Control Inspector I will be responsible for all aspects of inspection (receiving, in-process and final). In addition, this position will provide QSR support for other QA activities such as calibration, environmental monitoring, product testing, label control, etc.

Requirements

High School Diploma required.
0-2 years industry experience.
Medical device experience and working knowledge of QSR a must
Attention to detail and accuracy a must
Must have excellent documentation skills
Team player, good written/oral communicator
Must be organized and able to coordinate activities with outside vendors

Nice To Haves

Experience working in a clean room and/or performing in-process assembly and manufacturing verification inspections desirable

Responsibilities

Receiving inspection of components following procedures, specifications and drawings.
Utilize a variety of standard metrology equipment, including: Optical comparator, height gauge, master height gauge, CMM, Vision Metrology System (VMS, e.g., Smartscope), calipers, micrometers, surface table, gauge blocks, pin gauges, dial indicators, durometer, measuring microscope, hardness testers, pull force testers, surface roughness testers, etc.
Read engineering drawings and interpret geometric dimensioning and tolerancing.
Review associated paperwork, complete inspection records using good documentation practices, and release components.
Program the Smartscope to run automatic routines for multiple part inspections. (Level 2 and higher)
Write clear and concise procedures for inspection of components, machined tubing, etc. (Level 2 and higher)
Carefully handle and process extremely small components without damaging them.
Perform Line Clearance for Operations activities
Inspect and release labeling
Review device history records for lot release. Ensure all quality records meet good documentation practices in accordance with internal procedures.
Perform inspections on components and assemblies in manufacturing
Review device history records for lot release. Ensure all quality records meet good documentation practices in accordance with internal procedures.
Perform final inspection on finished goods
Inspect finished goods for proper labels, packaging, tamper seals and product in accordance with procedures.
Coordinate final inspection activities with outside vendors, i,e, LAL, peel testing
Perform in-house peel testing on sealed packages
Maintain sample retain area
Work with engineering in the design of high quality inspection / metrology fixtures.
Support equipment and process validation activities by inspecting process outputs
Conduct periodic compliance audits of manufacturing operations and procedures for cGMP compliance.
Ensures on a daily basis quality records and company practices are compliant with internal procedures and regulations.
Coordinate the monthly environmental monitoring of the cleanrooms.
Coordinate quarterly dose audits.